Randomized Phase III Trial of Irinotecan Plus Cisplatin versus Etoposide Plus Cisplatin in Chemotherapy-Naive Korean Patients with Extensive-Disease Small Cell Lung Cancer.

ABSTRACT:

Purpose

This randomized phase III study was designed to compare the efficacy and safety of irinote-can plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC).

Materials and methods

Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival.

Results

A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were

SUBMITTER: Kim DW 

PROVIDER: S-EPMC6334001 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature